Enforcement Discretion for Unapproved PEPs Ended April 28

May 5, 2010 10:42 am

Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Compliance has issued notice that April 28, 2010, was the last day that FDA exercised enforcement discretion for unapproved pancreatic enzyme products (PEPs). FDA considers all distributors (including wholesalers) subject to the Federal Register notices concerning these products. Firms distributing unapproved PEPs after April 28, 2010, are at risk of regulatory action. 

Because FDA recently approved Johnson and Johnson’s (J/J) Pancreaze™ PEP product, the agency will exercise enforcement discretion for J/J’s unapproved product Pancrease® MT for a short period beyond April 28. FDA intends for this discretion to accommodate patients who do not wish to switch to another approved product and then switch again to J/J’s approved product once it is launched. FDA will therefore not object if J/J and wholesalers distribute J/J's unapproved product (Pancrease MT) until May 31, 2010. Retail distribution centers (eg, chain pharmacies) and independent pharmacies may continue distributing their inventory of Pancrease MT within their internal distribution network until July 31, 2010, when Pancreaze™ is available.